Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-30 @ 3:26 PM
Study NCT ID:
NCT06757257
Status:
RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Special Drug Use-results Survey for Long-term Use (Fostamatinib)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C523665', 'term': 'fostamatinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 149}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2024-12-26', 'studyFirstSubmitQcDate': '2024-12-26', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Idiopathic Thrombocytopenic Purpura']}, 'descriptionModule': {'briefSummary': 'The purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for Japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.', 'detailedDescription': 'The purpose of this survey is evaluating the safety and efficacy of long-term administration of fostamatinib for Japanese patients with chronic idiopathic thrombocytopenic purpura under actual conditions of use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic idiopathic thrombocytopenic purpura who are treatment with fostamatinib for the first time.'}, 'identificationModule': {'nctId': 'NCT06757257', 'briefTitle': 'Special Drug Use-results Survey for Long-term Use (Fostamatinib)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Special Drug Use-results Survey for Long-term Use (Fostamatinib)', 'orgStudyIdInfo': {'id': 'TLPMS01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'fostamatinib treatmented', 'interventionNames': ['Drug: fostamatinib']}], 'interventions': [{'name': 'fostamatinib', 'type': 'DRUG', 'description': 'oral administration', 'armGroupLabels': ['fostamatinib treatmented']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo and Japanese Other Cities', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Kazunori Abe, director', 'role': 'CONTACT', 'email': 'rinsyousiken@pharm.kissei.co.jp', 'phone': '0356843575'}], 'facility': 'Research site'}], 'centralContacts': [{'name': 'Kazunori Abe, director', 'role': 'CONTACT', 'email': 'rinsyousiken@pharm.kissei.co.jp', 'phone': '0356843575'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}